Compliance & Inspections
Inspection readiness, USP 795, 797, and 800, standard operating procedures, and vendor due diligence for Tennessee community and compounding pharmacies, from a former deputy general counsel at the Department of Health.
Eleven years inside Tennessee healthcare regulation, including as deputy general counsel at the Department of Health.
Licensed in Tennessee, with federal practice before the DEA, FDA, and HHS nationwide.
The healthcare division of Litson PLLC, ready if a matter reaches court.
How we approach it
A routine inspection is the Board’s way of confirming that the systems inside a pharmacy work the way the law expects them to, and an inspector who walks in with a checklist is simply doing that job well. Matt Gibbs spent more than eleven years inside Tennessee healthcare regulation, including as deputy general counsel at the Department of Health, where he advised and trained the people conducting those visits, so he knows which records get pulled first, which questions tend to follow, and how a well-run pharmacy demonstrates that its practices match its paperwork before anyone has to ask.
For compounders, the baseline is set by USP 795, 797, and 800, and the layers of state and federal oversight that sit on top of them. Tennessee’s rules for non-sterile compounding remain in process, which means an operator who waits for a final rule to define the standard is already behind the standard the inspector will apply, so we help clients build to the USP chapters now, document their environmental controls, and keep standard operating procedures current as the practice grows. Growth itself draws attention, and it should, because a pharmacy that doubles its volume has usually changed its sourcing, its staffing, and its workflow along the way.
That is where the quieter work lives: knowing who your vendors are, verifying that a new supplier is legitimate before the first order ships, reviewing the website and advertising claims that manufacturers and regulators now read closely, and reviewing the contracts and policies that hold the operation together. Most of it fits comfortably inside a flat monthly membership, so the questions get asked while they are still small, and the inspection stays what it is meant to be.
What we handle
The systems an inspector checks, built and maintained before the visit.
Mock walk-throughs, record reviews, and staff preparation so a routine inspection stays routine.
Standing with you during and after a visit, and answering deficiencies completely and on time.
Sterile, non-sterile, and hazardous-drug compounding programs built to the USP chapters and state and federal expectations.
Drafting and updating the SOPs, logs, and training records that show the systems actually run.
Verifying suppliers, reviewing vendor agreements, and catching sourcing questions before they become findings.
Reviewing product claims, compounded-drug marketing, and disclosures that regulators and manufacturers read closely.
Unlimited questions, SOP and vendor-agreement review, website review, and inspection readiness all sit inside the membership tiers. Responding to a formal investigation, a citation, or a disciplinary action is scoped separately with a clear estimate before work begins, so there is never a surprise about what is covered.
Common questions
An inspector is checking whether the systems inside the pharmacy match what the law and the pharmacy’s own policies say should be happening, which usually means licenses and registrations, controlled-substance records, compounding logs and environmental controls, labeling, storage, and the standard operating procedures behind all of it. Inspectors compare what they see against what they saw last time, so a pharmacy that has grown or changed its services should expect questions, and they should, because differences warrant questions.
USP 795 governs non-sterile compounding, USP 797 governs sterile compounding, and USP 800 governs the handling of hazardous drugs, and each sits underneath a layer of state and federal oversight with its own requirements. Tennessee’s rules for non-sterile compounding remain in process, so the practical approach is to build the program to the USP chapters now and document it, because that is the baseline an inspector will apply either way.
Yes, this is the heart of it. Inspection readiness, SOP review, vendor and contract review, website review, and unlimited questions are what the membership tiers are built around. If an inspection turns into a formal investigation or a disciplinary action, that work is scoped and estimated separately, and the preparation that came before it is usually the reason it goes well.
Start before the first order. Verify licensure and registration in every state that requires it, ask for the documentation a regulator would ask you for, and read the vendor agreement for who bears the risk if a product turns out to be something other than what was promised. Sourcing decisions are one of the first things an investigator traces when a product question arises, so a few hours of diligence up front tends to save a great deal later.
Talk to Matt
15 minutes with Matt Gibbs. Skip the long intake form and get a straight answer on whether we can help.
Schedule a free callFrom the blog